GeM

AOC

Goods

Pregnancy Rapid Test Kits

PRODUCT

Pregnancy Rapid Test Kits

Employees State Insurance Corporation (esic)

24 Paraganas South, West Bengal

Amount: Refer DocsCloses: 28 Nov 2019Closed

Timeline

Published18 Nov 2019
Closed28 Nov 2019
Awarded28 Nov 2019

Bids

6 Bids28 Nov 2019

#	Company	Offered Item	Amount	Rank	Status
1	CHATURBHUJ INFRASTRUCTURE L1₹76,500Qualified Make: PREGA NEWS Model: Prega news 0 BEEJ BHANDAR ROAD KARERA KARERA SHIVPURI MADHYA PRADESH 473660 \| SHIVPURI \| MADHYA PRADESH \| 473660	Make: PREGA NEWS Model: Prega news	₹76,500	L1	Qualified
2	K R LYNCH & COMPANY L2₹1.0 L+₹24,000 (31.4%)Qualified Make: PREGA NEWS Model: PREGA NEWS 113 CHITTARANJAN AVENUE KOLKATA WEST BENGAL 700073 \| KOLKATA \| WEST BENGAL \| 700073	Make: PREGA NEWS Model: PREGA NEWS	₹1.0 L+₹24,000 (31.4%)	L2	Qualified
3	Acer Biomedicals LLP Disqualified Make: BIOLINE Model: First View Pregnancy Card 76 76A 3RD FLOOR 453 455 CHIKHAL HOUSE KALBADEVI ROAD KALBADEVI MUMBAI MAHARASHTRA 400002 \| MUMBAI \| MAHARASHTRA \| 400002	Make: BIOLINE Model: First View Pregnancy Card	-	-	Disqualified
4	Bio Medicare Disqualified Make: SIDAK LIFE CARE Model: Sidak, Preg Clear PLOT NO 115 KH NO 906 GROUND FLOOR FRIENDS ENCLAVE MUNDKA NEW DELHI 110041 WEST DELHI DELHI 110041 \| WEST DELHI \| DELHI \| 110041	Make: SIDAK LIFE CARE Model: Sidak, Preg Clear	-	-	Disqualified
5	DIAGNOCURE (INDIA) Disqualified Make: Drop News Model: Drop News FIRST FLOOR SHED NO 2 ELECTRONIC COMPLEX CHAMBAGHAT SOLAN HIMACHAL PRADESH 173213 \| SOLAN \| HIMACHAL PRADESH \| 173213	Make: Drop News Model: Drop News	-	-	Disqualified MSE, Category: General

Tender Value

Refer Docs

EMD Value

Exempted

Closing Date

28 Nov 2019, 4:00 pmClosed

Work Description

Pregnancy Rapid Test Kits

Tender Information

Tender ID

1475071

Reference Number

GEM/2019/B/428256

Product Category

Pregnancy Rapid Test Kits

Period of Work

30 days

Location

West Bengal; 24 Paraganas South

Bid Type

PRODUCT

Source Website

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Documents Required

13 documents required · 13 mandatory

RequiredOEM Authorization Certificate Bid to RA enabled No Pregnancy Rapid Test Kits ( 3000 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description Pregnancy Rapid Test Kit * Detection Type Quantitative * Testing Principle Single Step

Requiredself performing sandwiched immunoassay using colloidal gold and anti hCG antibodies in lateral flow immunochr omatography format * 1/5 Specimen Required for testing Urine * Ability to Evaluate Negative or Positive test result Yes * Sensitivity ≥ 25 milli I.U/ml of urine * Specificity 100 % (no cross reactivity with other gonadotropin hormones like LH

RequiredFSH etc) * Should have built in control for confirmation that the test has been performed correctly Yes * Nitrocellulose paper coated with anti HCG antibodies for Test band and appropriate reagents for control band Yes * The Kit should be stable at room temperature Yes * The supplier should ensure maintenance of recommended temperature during storage and transportation of Kit Yes * KIT CONTENTS Main item in test kit for performing the test Card/Cassete * Material of Cassete ABS or PP * Disposable dropper for urine specimen addition to be provided with each test pouch Yes * Every test pack should have moisture indicating silica gel pouch Yes * Packaging insert in English detailing the principle

Requiredcomponents

Requiredmethodologies

Requiredvalidity criteria

Requiredperformance c haracteristics

Requiredbio- safety

Requiredlimitations of assay

Requiredstorage condition

RequiredYes * 2/5 manufacturing and expiry dates and methods of disposal to be provided with each kit Price offered Price offered should be per each card/cassette * PACKAGING Pack Size 100 Tests pack * Each test kit should be indivdually packed in a moisture proof pouches Yes * Pouch specification Triple layerd laminated pouch having aluminium foil in the middle layer * Packing Laminated Printed cartons and the cartons should be packed in suitable corrugated shipper box for dispatch * CERTIFICATIONS & REPORTS The kit should have approval of the statutory authority in its country of origin Yes * The Kit should be registered and licensed in India by DCGI in case of imported kits NA for domestically manufactured kits * Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 NA for imported kits * Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act

Required1940 For sale or distribution * Drug License Number - * Drug License Date - * Manufacturer certifications GMP * GMP/WHO GMP Certification Number - * GMP/WHO GMP Certification Date - * 3/5 ISO 13485 Certified Manufacturer No * Product Certification NA * Four digit number of notified body If product is EU-CE certified - * Product Certification Number - * Product Certification Date - * Product Certification Issuing Authority - * Availability of test report/performance evaluation report from Central GOVT/NABL/ILAC accredited Lab as well as in house test report to prove the conformity to the declared specification Yes * Submission of copies of all the certifications and test reports to buyer along with supplies Yes * SHELF LIFE Shelf Life (in months) from the date of manufacture 36 36 Or higher The product should have atleast 3/4 of the total shelf life at the time of dispatch to the consignee Yes * * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters

Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer. Additional Specification Documents

Items & Quantities

Item	Delivery Location	Qty	Delivery
Pregnancy Rapid Test Kits	-	3,000	-

Total: 3,000

Fee & Financial Details

EMD Fee Amount

Exempted

Important Dates

Last Activity

28 Nov 2019

Published

18 Nov 2019

Documents

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Tender Documents

bid_1475071.pdf

GEM_BID

Work Item Documents

termsCondition.pdf

OTHER

2657c7ca70287299b5181580fdb5a7ab.pdf

OTHER

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